Prescription drug · ANDA
Desloratadine NDC 72162-2308
Desloratadine 5 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-2308-1 | 7216223080172162230801 | 100 TABLET in 1 BOTTLE, PLASTIC (72162-2308-1)Marketed from May 7, 2024 | |
| 72162-2308-3 | 7216223080372162230803 | 30 TABLET in 1 BOTTLE, PLASTIC (72162-2308-3)Marketed from May 7, 2024 | |
| 72162-2308-5 | 7216223080572162230805 | 500 TABLET in 1 BOTTLE, PLASTIC (72162-2308-5)Marketed from May 7, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Desloratadine
- Generic name (nonproprietary)
- desloratadine
- Active ingredients
- Desloratadine — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 72162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078355
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 72162-2308_52ff3486-b017-428a-945a-743810c38e51SPL ID 52ff3486-b017-428a-945a-743810c38e51SPL set ID cf7f838b-4595-4c81-97b9-e1594347e1bdRxCUI 349420UNII FVF865388R
- Pharmacologic class
- Histamine-1 Receptor Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N472162230801followed by a unit qualifier and the quantityPackage 72162-2308-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Desloratadine Tablets are a histamine-1 (H1) receptor antagonist indicated for: • Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 12 years of age and older. ( 1.1 ) • Perennial Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 12 years of age and older. ( 1.2 ) • Chronic Idiopathic Urticaria: symptomatic relief of pruritus, reduction in the number of hives, and size of hives in patients 12 years of age and older. ( 1.3 ) 1.1 Seasonal Allergic Rhinitis Desloratadine Tablets are indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 12 years of age and older. 1.2 Perennial Allergic Rhinitis Deslo…
Excerpt only. Read the full label for complete information.
About NDC 72162-2308
- What is NDC 72162-2308?
- 72162-2308 is the product NDC for Desloratadine, Desloratadine 5 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Desloratadine.
- What is the active ingredient?
- Desloratadine.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 72162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Desloratadine?
- 11 other product NDCs are listed under this name. See all Desloratadine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Desloratadine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Desloratadine | Desloratadine 5 mg/1 | TabletOral | Morepen Bio Inc. | 87717-001 | 87717-0001-0187717-0001-02 |
| Desloratadine | Desloratadine 5 mg/1 | Tablet, Film coatedOral | Natco Pharma USA LLC | 69339-194 | 69339-0194-0169339-0194-05 |
| Desloratadine | Desloratadine 5 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-363 | 69452-0363-2069452-0363-30 |
| Desloratadine | Desloratadine 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-3975 | 50090-3975-0050090-3975-01 |
| Desloratadine | Desloratadine 5 mg/1 | TabletOral | Virtus Pharmaceuticals, LLC | 69543-107 | 69543-0107-1069543-0107-50 |
| Desloratadine | Desloratadine 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4794 | 50090-4794-00 |
| Desloratadine | Desloratadine 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6724 | 50090-6724-00 |
| Desloratadine | Desloratadine 5 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-153 | 68180-0153-0168180-0153-02 |
| Desloratadine | Desloratadine 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1000 | 71335-1000-0171335-1000-0271335-1000-03 |
| Desloratadine | Desloratadine 5 mg/1 | Tablet, Orally disintegratingOral | Dr. Reddy's Laboratories Limited | 55111-360 | 55111-0360-0655111-0360-31 |
Other NDCs under ANDA 078355
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Desloratadine | Desloratadine 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-3975 |
| Desloratadine | Desloratadine 5 mg/1 | TabletOral | Virtus Pharmaceuticals, LLC | 69543-107 |
| Desloratadine | Desloratadine 5 mg/1 | TabletOral | Morepen Bio Inc. | 87717-001 |